News & Analysis as of

Interstate Commerce Dept. of Justice

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

Tacoma Passes Moratorium on New Retail Stores, Medical Cooperatives

by Garvey Schubert Barer on

Thinking about opening a recreational store or medical cooperative in Tacoma? Better sit tight, at least for the time being. On Tuesday, January 13, 2016, the Tacoma City Council passed a “temporary moratorium on new...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

by Saul Ewing LLP on

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

New FCPA Decision: How Long is the FCPA’s Reach?

by Morrison & Foerster LLP on

A little more than a year after Deustche Telekom (“DT”) and Magyar Telekom entered into multi-million dollar settlements with the SEC and DOJ to resolve claims that the two companies violated the FCPA, three former Magyar...more

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